Ten-Day Quadruple Therapy Comprising Proton Pump Inhibitor, Bismuth, Tetracycline, and Levofloxacin is More Effective than Standard Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori Infection: A Randomized Controlled Trial
Ten-Day Quadruple Therapy Comprising Proton Pump Inhibitor, Bismuth, Tetracycline, and Levofloxacin is More Effective than Standard Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori Infection: A Randomized Controlled Trial
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DOI：
10.1038/ajg.2017.195
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发表时间：
2017-09-01
影响因子：
9.8
通讯作者：
Wu, Deng-Chyang
中科院分区：
文献类型：
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作者：
Hsu, Ping-I;Tsai, Feng-Woei;Wu, Deng-Chyang
目的：质子泵抑制剂(PPI)-阿莫西林-氟喹诺酮三联疗法在马斯特里赫特V/佛罗伦萨共识报告中被推荐为治疗幽门螺杆菌感染的二线药物。然而，这种标准挽救治疗的根治率并不理想。本研究的目的是比较esomeprazole-bismuth-tetracycline-levofloxacin疗法(TL四联疗法)和埃索美拉唑-阿莫西林-左氧氟沙星三联疗法(AL三联疗法)对幽门螺杆菌感染的抢救治疗的疗效。方法：连续接受一线治疗失败的幽门螺杆菌感染者随机分为TL四联疗法(埃索美拉唑40 mg bd，铋120 mg q.d，四环素500 mg q.d.d，左氧氟沙星500 mg o.d)。或AL三联疗法(埃索美拉唑40 mg，每日2次，阿莫西林500 mg，每日1次，左氧氟沙星500 mg，每日3次)。住了10天。治疗结束6周后评估幽门螺杆菌感染状况。结果：该研究在中期分析后终止。在TL四联疗法的50例患者中，49例(98.0%)Hp感染被成功根除。接受AL三联治疗的52例患者中，36例(69.2%)幽门螺杆菌感染治愈。意向处理分析显示，TL四联疗法的根治率明显高于AL三联疗法(差异：28.8%；95%可信区间：15.7%~41.9%；P<；0.001)。按方案分析得出类似的结果(97.8%vs.68.6%；P<；0.001)。两个治疗组的总体不良事件发生率(22.0%比11.5%)和药物依从性(90.0%比98.1%)具有可比性。亚组分析显示，无论是标准三联疗法(100%vs.75.0%；P=0.010)还是非铋四联疗法(95.0%vs.52.6%；P=0.003)失败的患者，TL四联疗法均优于AL三联疗法。结论：标准三联疗法或非铋四联疗法失败后，Tl四联疗法是抢救H.
OBJECTIVES: Proton pump inhibitor (PPI)-amoxicillin-fluoroquinolone triple therapy is recommended as a second-line treatment of Helicobacter pylori infection in the Maastricht V/Florence Consensus Report. However, the eradication rate of this standard salvage treatment is suboptimal. The objective of this study is to compare the efficacy of esomeprazole-bismuth-tetracycline-levofloxacin therapy (TL quadruple therapy) and esomeprazole-amoxicillin-levofloxacin triple therapy (AL triple therapy) in rescue treatment for H. pylori infection.METHODS: Consecutive H. pylori-infected subjects after failure of first-line therapies were randomly allocated to receive either TL quadruple therapy (esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) or AL triple therapy (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. H. pylori status was assessed 6 weeks after the end of treatment.RESULTS: The study was stopped after an interim analysis. Of 50 patients in the TL quadruple therapy, 49 (98.0%) had successful eradication of H. pylori infection. Cure of H. pylori infection was achieved in 36 of 52 patients (69.2%) receiving AL triple therapy. Intention-to-treat analysis demonstrated that TL quadruple therapy achieved a markedly higher eradication rate than AL triple therapy (difference: 28.8%; 95% confidence interval: 15.7% to 41.9%; P < 0.001). Per-protocol analysis yielded a similar result (97.8% vs. 68.6%; P < 0.001). The two treatment groups exhibited comparable frequencies of overall adverse events (22.0% vs. 11.5%) and drug compliance (90.0% vs. 98.1%). The subgroup analysis showed that TL quadruple therapy was superior to AL triple therapy in patients with failure of either standard triple therapy (100% vs. 75.0%; P = 0.010) or non-bismuth quadruple therapy (95.0% vs. 52.6%; P = 0.003).CONCLUSIONS: Ten-day PPI-bismuth-tetracycline-levofloxacin quadruple therapy is a good option for rescue treatment of H. pylori infection following failure of standard triple or non-bismuth quadruple therapy.